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临床试验/NCT02662777
NCT02662777已完成不适用

International, Prospective, Multicenter Registry Designed to Collect Clinical Evidence for Endoscopic Vacuum Treatment Using Eso-SPONGE® for Anastomotic Leakage After Esophageal Resection or Iatrogenic or Spontaneous Esophageal Perforation.

Aesculap AG17 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Aesculap AG
入组人数
108
试验地点
17
主要终点
Healing rate of the esophageal anastomosis leakage or esophageal perforation

研究概览

简要总结

This international, prospective and multicenter registry was designed to collect clinical evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after esophageal resection or iatrogenic or spontaneous esophageal perforation.

详细描述

Anastomotic Leakages or other defects in the upper gastrointestinal tract can have serious consequences for the affected patients. Different parameters, like the size, location, time to diagnosis of the lesion, but also the general condition of the patient, have a significant influence on the clinical outcome of the patient. Often this situation is accompanied by symptoms of sepsis and a significant morbidity rate with corresponding substantial mortality rate. For this reason the treatment of this clinical situation is often a challenge for the clinician.

Besides surgical examination and the endoscopic stent system, good experiences have been obtained with the Endo-SPONGE® therapy for the lower gastrointestinal tract. In the future the endoluminal vacuum therapy for the upper gastrointestinal is available, too, with Eso-SPONGE®.

Eso-SPONGE® represent an innovative therapy concept for the treatment of this problem in the upper gastrointestinal tract, which can contribute significantly to the reduction of morbidity and mortality of the patients.

The overall success rate of endoscopic esophageal vacuum therapy in the literature ranges from 80-100%. Currently only cohort studies including a small number of patients have been performed and published. Therefore an international, prospective and multicenter registry was designed to collect clinical evidence for Eso-SPONGE treatment concept in a large population under daily clinical routine.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Endoscopic vacuum therapy (EVT) of anastomotic leakage after esophageal resection or spontaneous or iatrogenic perforations
  • age > 18 years
  • written informed consent

排除标准

  • 未提供

结局指标

主要结局

Healing rate of the esophageal anastomosis leakage or esophageal perforation

时间窗: until day of discharge (approximately 2 weeks)

Reduction of the cavity, endoscopic vacuum therapy no longer necessary

次要结局

  • Number of Eso-SPONGE® changes(until day of discharge (approximately 2 weeks))
  • Total number of sponges used(until day of discharge (approximately 2 weeks))
  • Average replacement intervals(until day of discharge (approximately 2 weeks))
  • Duration of endoscopic vacuum therapy(until day of discharge (approximately 2 weeks))
  • Complication Rate(until day of discharge (approximately 2 weeks))

研究者

发起方
Aesculap AG
申办方类型
Industry
责任方
Sponsor

研究点 (17)

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